Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

About this trial

Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions.

This retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥18 years

LC-OCT performed as part of diagnostic evaluation between January 2025 and June 2025 at Mohs clinics in the Netherlands

Histopathological results (biopsy or excision) and/or 6-12 month clinical follow-up data available

Disqualifiers

Patients <18 years of age

Cases without histopathological confirmation or available follow-up data

Trial population

Patients with lesions clinically suspected for BCC who visited the Mohs Clinics between January 2025 and June 2025 and underwent LC-OCT imaging as part of the diagnostic work-up.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

297 Participants
are grouped into 1 trial group
Group A: Patients wit BCC suspected lesions who underwent LC-OCT imaging

Trial outcomes

Primary outcomes

1

Tumor free survival

Tumor-free survival rate at 6-12 months follow-up among patients with lesion(s) clinically suspicious for BCC, who were treated based on an LC-OCT-guided diagnosis, with treatment success defined as the absence of residual or recurrent tumor.

Time frame
From enrollment to end of treatment at 6-12 months.

Secondary outcomes

1

Diagnostic accuracy for BCC detection

Diagnostic parameters (sensitivity, specificity, positive predictive value, negative predictive value, diagnostic odds ratio) will be estimated for diagnosis made by LC-OCT (with histopathology serving as reference standard).

Time frame
From enrollment to end of treatment at 6-12 months.
2

Treatment strategies

Descriptive evaluation of treatment strategies following LC-OCT-guided diagnosis (ie surgical, topical).

Time frame
From enrollment to end of treatment at 6-12 months.
3

Number of performed LC-OCT scans

Descriptive evaluation: number of LC-OCT scans performed

Time frame
From enrollment to 6-12 months
4

Lesion characteristics

Descriptive: lesion characteristics (size, location)

Time frame
At baseline

Other outcomes

Sponsors and contacts

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